Phase II Study of Pre-Operative Stereotactic Ablative Radiation Therapy With or Without Caloric Restriction in Early Stage Breast Cancer Patients

What this Trial Is About

Researchers are evaluating the effect of calorie reduction combined with stereotactic ablative radiation therapy SABR in patients with early-stage breast cancer. This phase II trial aims to see if reducing calorie intake during pre-operative SABR decreases tumor tissue more than SABR alone. SABR delivers focused, intense radiation to the tumor while sparing nearby organs, and the study also explores changes in tumor and patient characteristics, surgical outcomes, and patient satisfaction. Participants are randomly assigned to one of two groups. One group receives standard dietary advice and SABR every other day for five treatments, followed by surgery with sentinel lymph node biopsy within 4 to 12 weeks after SABR. The other group starts a 25% calorie-restricted diet one week before SABR, continues it during the radiation treatment for 6 to 12 weeks, and then undergoes the same SABR and surgery schedule. Both groups are monitored for tumor response and surgical results. During the study, participants undergo various assessments including contrast-enhanced mammography, tissue and blood sample collection, and quality-of-life questionnaires. Researchers measure tumor cellularity reduction, sentinel lymph node identification, surgical complications, patient-reported health outcomes, and cosmetic results. Follow-up visits occur 3 to 6 weeks after surgery and again at 6 months to monitor longer-term outcomes. The trial seeks to better understand how calorie restriction combined with radiation may affect breast cancer treatment.

Pre-operative SABR With and Without Caloric Restriction for Early Stage Breast Cancer